Blog
RSS FeedPosted by Michael Wonder on 01 Mar 2025
Enhertu recommended for approval in the EU by CHMP for patients with HER2 low or HER2 ultra-low metastatic breast cancer following at least one endocrine therapy
28 February 2025 - Recommendation based on DESTINY-Breast06 Phase 3 trial results which showed Enhertu demonstrated superiority versus chemotherapy with ...
Posted by Michael Wonder on 01 Mar 2025
Novartis oral Fabhalta (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy
28 February 2025 - If approved, Fabhalta will be the only medicine indicated to selectively target the underlying cause of C3G, ...
Posted by Michael Wonder on 01 Mar 2025
Linvoseltamab recommended for EU approval by the CHMP to treat relapsed/refractory multiple myeloma
28 February 2025 - Regeneron Pharmaceuticals today announced that the EMA's CHMP has adopted a positive opinion recommending conditional marketing ...
Posted by Michael Wonder on 24 Feb 2025
The EMA has approved an additional subcutaneous administration option for Takhzyro (lanadelumab) for patients aged 12 years and above with recurrent attacks of hereditary angioedema
24 February 2025 - Takhzyro solution for injection in 2 mL pre-filled pen is now approved to facilitate subcutaneous administration in ...
Posted by Michael Wonder on 21 Feb 2025
Gilead’s seladelpar granted conditional European marketing authorisation for the treatment of primary biliary cholangitis
20 February 2025 - Now approved, seladelpar can provide an important treatment option for people living with the rare liver Disease ...
Posted by Michael Wonder on 19 Feb 2025
European Commission approves Biocon Biologics’ ustekinumab biosimilar
18 February 2025 - Biocon announced today that the European Commission granted marketing authorisation in the European Union for Yesintek, ...
Posted by Michael Wonder on 18 Feb 2025
Welireg (belzutifan) receives first European Commission approval for two indications
18 February 2025 - Welireg is the first and only oral hypoxia-inducible factor-2 alpha inhibitor approved in the European Union ...
Posted by Michael Wonder on 17 Feb 2025
Samsung Bioepis gains European Commission approval for denosumab biosimilar (Obodence, Xbryk)
16 February 2025 - Obodence and Xbryk approved by the European Commission for all indications referencing Prolia and Xgeva, respectively. ...
Posted by Michael Wonder on 16 Feb 2025
European Commission approves Egetis’ Emcitate (tiratricol) as the first and only treatment for patients with MCT8 deficiency
13 February 2025 - Egetis Therapeutics today announced that the European Commission has approved Emcitate (tiratricol) for the treatment of ...
Posted by Michael Wonder on 15 Feb 2025
European Commission approves CSL and Arcturus Therapeutics’ Kostaive, the first self-amplifying mRNA COVID-19 vaccine
14 February 2025 - Kostaive represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to ...
Posted by Michael Wonder on 14 Feb 2025
European Commission approves CSL's Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema
13 February 2025 - Supported by the Phase 3 VANGUARD trial, this marks the third regulatory approval for Andembry, which was ...
Posted by Michael Wonder on 11 Feb 2025
Heart drug Beyonttra (acoramidis) approved in EU for treatment of transthyretin amyloidosis in adults with cardiomyopathy
11 February 2025 - Approval based on positive results from Phase 3 ATTRibute-CM study. ...
Posted by Michael Wonder on 06 Feb 2025
Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
5 February 2025 - Serplulimab is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of extensive stage small-cell lung ...
Posted by Michael Wonder on 04 Feb 2025
CHMP recommends subcutaneous Rybrevant (amivantamab) for the treatment of patients with advanced EGFR mutated non-small cell lung cancer
3 February 2025 - Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic endpoints, ...
Posted by Michael Wonder on 03 Feb 2025
Imfinzi recommended for approval in the EU by CHMP as first and only immunotherapy for limited-stage small cell lung cancer
3 February 2025 - Recommendation based on ADRIATIC Phase 3 trial results which showed a 27% reduction in the risk ...